(47 days)
The AST (SGOT) reagents, product No. 117-01 and 117-02 are intended for Invitro determination of AST (SGOT) in serum, or plasma.
Not Found
This document is a 510(k) clearance letter from the FDA for a device named "AST (SGOT)". The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the regulatory requirements for marketing. However, this letter does not contain specific acceptance criteria or details of a study proving the device meets those criteria in the way a clinical trial report or performance study summary would.
Therefore, I cannot provide the requested information from the given text because the document is a regulatory clearance letter, not a detailed performance study report.
Here's why and what's missing:
- Acceptance Criteria & Reported Performance: The letter states the device is "substantially equivalent," which is the regulatory hurdle, but doesn't define quantitative performance metrics (like accuracy, sensitivity, specificity, or precision) that would be acceptance criteria, nor does it list the specific results of a study against such criteria.
- Sample Size, Data Provenance, Experts for Ground Truth, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set Size & Ground Truth Establishment: These are all details typically found in a clinical study report or a 510(k) summary (which sometimes includes more detail than the clearance letter itself). This letter only grants clearance based on the submission, it doesn't contain the specifics of that submission's performance data.
The "Indications For Use" section on page 2 simply states the device's intended use: "The AST (SGOT) reagents... are intended for In vitro determination of AST (SGOT) in serum, or plasma." This describes what the device does, not how well it does it or the data proving its performance.
To answer your questions, one would need to review the actual 510(k) submission (including the summary of safety and effectiveness data) that the FDA reviewed to make this substantial equivalence determination, not just the clearance letter.
§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.
(a)
Identification. An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.